Current advances in biotechnology have introduced a variety of new therapeutic products to the market. Nowhere is this more true than in the medical industry. Instead of traditional drugs taken orally or intravenously, many of the new therapies involve the delivery of biological or cellular products directly to the patient. For example, cellular transplantation has recently emerged as a potential new treatment for many diseases or physical defects due to injury that could result in the loss of specialized cells within organ systems, eventually leading to organ system failure. The potential to treat these conditions with cell-based therapies holds promise for tissue/organ repair with the ultimate goal to regenerate and restore normal function.
The field of regenerative biology as it applies to regenerative medicine is an increasingly expanding area of research with hopes of providing therapeutic treatments for diseases and/or injuries that conventional medicines and even new biologic drug therapies cannot effectively treat. Extensive research in the area of regenerative medicine is focused on the development of cells, tissues and organs for the purpose of restoring function through transplantation. Replacement, repair and restoration of function is best accomplished by cells, tissues or organs that can perform the appropriate physiologic/metabolic duties. Several strategies are currently being investigated and include cell therapies derived from a variety of stem cells, including bone marrow, mesenchymal stem cells, cord blood stem cells, embryonic stem cells, as well as cells, tissues and organs from genetically modified animals.
A number of pre-clinical models as well as clinical applications involving cell therapy currently exist or are being explored. For example, cell therapies have been used to rebuild damaged cartilage in joints, repair spinal cord injuries, strengthen a weakened immune system, treat autoimmune diseases such as AIDS, and help patients with neurological disorders such as Alzheimer's disease, Parkinson's disease, and epilepsy. Further uses have included the treatment of a wide range of chronic conditions such as arteriosclerosis, congenital defects, and sexual dysfunction. Cell therapy has also been explored as a cancer treatment.
Another application of autologous cell transplantation involves the use of cell therapy to treat heart tissue damaged by myocardial infarction (MI). In one particular application, myoblasts harvested from a muscle biopsy can be transplanted as an adjunct to coronary artery bypass surgery, such as for example, by injecting the myoblast cells directly into a scarred or damaged heart, i.e., into the scar tissue or pre-infarct zone of damaged myocardium. Such a treatment technique would address acute injuries of the myocardium while also slowing or preventing the progression of congestive heart failure or scar formation.
With the clinical promise of novel therapeutic strategies comes new challenges. Because these cellular therapeutic products are living cells and delivered to the surgeon or care provider, it is desirable to understand not only how to reliably produce these products but also how to deliver them to the surgeon or care provider while preserving their viability and therapeutic properties. Accordingly, the need for temperature-sensitive packaging becomes critical as these cell therapies are brought to market. There is thus a need for storage and container systems that take into account the biological and physical requirements of transporting live cells, and in particular the effects of temperature constraints of the shipping process on the biological products. Specifically, there is a need for a storage and container system that can maintain the viability and therapeutic properties of the cells for a sufficient period of time during shipping or transport.